U.S. House panel seeks FDA documents on meningitis-linked firm

October 17, 2012|Reuters

WASHINGTON (Reuters) - A U.S. congressional committee that oversees drug safety issues asked the Food and Drug Administration on Wednesday to provide documents on federal and state inspections of a Massachusetts pharmacy linked to a deadly meningitis outbreak that has killed 19 people.

In a letter to FDA Commissioner Margaret Hamburg, the House of Representatives Energy and Commerce Committee said it was requesting documents dating back to 2004 as part of a probe to determine what actions regulators took after they concluded that the pharmacy's facilities posed potential risks to public health.

"Given the risk to public health posed by this outbreak, the committee expects the FDA to comply with this request promptly," said the letter signed by Republican panel chairman Fred Upton, top Democrat Henry Waxman and six other committee members.

The panel requested FDA documents pertaining to the New England Compounding Center, which is at the heart of a meningitis outbreak linked to tainted steroid treatments and other products.

Lawmakers also sought documents involving Ameridose LLC, a second pharmacy that shares ownership with NECC, as well as communications with state regulators and Hamburg's office.